| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00787-1 |
| Product Name/Description |
BrightView X and BrightView XCT with software versions 2.5.2 and earlier, 2.5.3 and 2.5.4
(Nuclear medicine gamma camera and SPECT/CT diagnostic imaging systems)
Model numbers: 882478, 882482
ARTG numbers: 117642, 17440 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
During a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. If this occurs, contact sensors would pause the scan. A certain set of conditions identified in the customer letter are required to create the situation.
There have been no reports of any injuries associated with this issue. However, users are reminded to ensure patients are observed closely at all times, and the E-Stop is activated to prevent contact with the patient, if required. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing users to instructions to follow in order to prevent the issue from occurring. A software upgrade will be implemented as a permanent correction.
August 2016 Update: Philips is providing an updated letter to users to provide clarity around the requirements for the situation to occur.
This action has been closed out on 08/11/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |